# FDA recall Z-2209-2023

> **Cytocell Ltd.** · Class II · device recall initiated 2023-05-24.

## Product

RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.

## Reason for recall

DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.

## Distribution

US Nationwide distribution in the states of CA, FL, OH, & SC.

## Key facts

- **Recall number:** Z-2209-2023
- **Recalling firm:** Cytocell Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-24
- **Report date:** 2023-07-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cambridge, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2209-2023

## Citation

> AI Analytics. FDA recall Z-2209-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-2209-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*